BEUDAMED
    FDA Recall Open, Classified

    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

    Recall: Z-0885-2022 · Initiated January 19, 2022

    Recall

    Recall Number
    Z-0885-2022
    Event Number
    89673
    Firm
    Volcano Corporation
    FEI Number
    2939520
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 19, 2022
    Address
    2451 Mercantile Dr, Rancho Cordova, CA, 95742-6326

    Description

    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

    Reason

    If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

    Action

    On 01/19/22, correction notices were sent to customers who were informed of the following: If FFR measurement(s) are made prior to an iFR/FFR co-registration in the same procedural session. The user will be visually alerted with a warning message "Insufficient data, distal segment is not co-registered" on the display about the distal segment not being co-registered. The user may also notice the initial iFR/FFR co-registered distal value(s) will be higher than the correctly displayed distal iFR/FFR value(s). Recommended Course of Action: If prior to the iFR/FFR Pullback on the system, FFR measurement(s) were performed within the same procedural session, the user needs to follow any one of the following steps just prior to the iFR/FFR pullback to mitigate the issue: - Click on the "iFR Spot" button on the IntraSight system and perform at least one iFR Spot measurement. OR: - Go back to the "case menu" on the system and then re-enter the LIVE screen to perform iFR pullback. OR: - Exit the procedure and then re-enter the procedure using "Continue Procedure" option. Philips is in the process of updating the Operators Manual to ensure the issue, mitigations, and workarounds are effectively highlighted to inform the user. Notify all system users within your facility of this communication and retain a copy for reference. Send a copy of this notification to any customer to whom you have distributed the affected product to. Customers requiring additional information can contact customer service: 1-800-228-4728, Option 2, [email protected] Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST

    Distribution

    US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE OUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR, EG, FI, HK, FR, NO, DK, BE, AT, IT, CO, KW, MX, PS, QA, CY, CA, TW, LV, SE, HR, SI, MY, KR, IL, TH, AU, BR, CL, SK, CH, LB, OM, ID, PK, IE, NZ, PR, RO, MM, AR, RS, RU, PA, KE, UZ

    Quantity

    3,216